BOSTON -- When it came on the market more than three years ago, Gardasil was widely touted and marketed as the first vaccine that might prevent cancer. It was approved for girls as young as 9 years old to protect against the four most common strains of human papilloma virus, which can lead to cervical cancer.

Now the Journal of the American Medical Association has published a compilation of the more than 10,000 complaints reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) since June 2006 when Gardasil was granted FDA approval.

NewsCenter 5's medical editor Dr. Timothy Johnson said VAERS is a passive reporting system, meaning there is no way to know if the reported problems were caused by Gardasil or are a coincidence. VAERS does not investigate the validity of complaints.

VAERS records show that there was an average of 53.9 reports per 100,000 vaccine doses distributed. Six percent were serious, including 32 deaths. Merck, the company that makes Gardasil, stands by its safety and effectiveness.

An editorial also in the current edition of JAMA is reigniting the question many parents are asking themselves -- do the benefits of Gardasil outweigh the risks?

The editorial, written by Charlotte Huag, MD, Ph. D., MSc, begins by asking, “When do physicians know enough about the beneficial side effects of a new medical intervention to start recommending or using it?”

Huag continues, “The theory behind the vaccine is sound: if HPV infection can be prevented, cancer will not occur. But in practice the issue is more complex. First there are more than 100 different types of HPV.”

She goes on to write, “The virus does not appear to be very harmful because almost all HOV infections are cleared by the immune system. In a few women, infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now. The true effects of the vaccine can be determined only through clinical trials and long-term follow-up.”

"For the first time in my career, I don't know whether or not to recommend a vaccine for the general population that is targeted -- young girls," Johnson said. "Therefore I am going to say that any parent considering this vaccine for their daughter should read the editorial in JAMA and then talk to their doctor before deciding.”

The full text of Huag’s editorial can be found in the Aug. 19, 2009, edition of the Journal of the American Medical Association.